• 25 mg lidocaine
• 25 mg prilocaine

• 20 mg macrogol glycerol hydroxystearate
• Carbomer 974 P
• Sodium hydroxide for pH adjustment
• water, purified
• cellulose
• Polyethylene film, aluminized
• Polyethylene acrylate adhesive

TAPFI, lidocaine, prilocaine, medicated plaster indication

• This medicine contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics.
• It works by temporarily numbing the surface of the skin. It is applied to the skin before certain medical procedures. This will help eliminate the pain on the skin. However, you may still feel pressure or touch.
• adults, adolescents and children
  • It can be used to numb the skin before:
    • a needle stick (e.g. when you get an injection or for a blood test),
    • minor surgical interventions on the skin.

TAPFI, lidocaine, prilocaine, medicated plaster dosage

• Always use this medicine exactly as described or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• Where the medicated patch is placed, how many patches are used and how long it is left on the skin depends on what it is needed for.
• Your doctor, pharmacist or nurse will apply the medicated plaster or show you how to correctly apply it yourself.
• Do not use the patch on the following skin areas:
  • Cuts, abrasions or wounds
  • Areas with a rash or eczema
  • near the eyes
  • in the mouth
• Use on the skin before minor procedures (such as a needle stick or minor skin surgery):
  • The medicated plaster is stuck onto the skin. Your doctor, pharmacist or nurse will tell you where to stick it.
  • The medicated plaster is removed immediately before the procedure.
  • One or more patches are usually applied to adults and adolescents aged 12 and over.
  • In adults and adolescents aged 12 and over, the medicated plaster is applied at least 60 minutes before the procedure. However, do not stick it on more than 5 hours before the procedure.
  • In children, how many medicated plasters are used and how long they are used depends on their age. Your doctor, pharmacist or nurse will tell you how many medicated plasters you need and when to put them on.
• children
  • Use on the skin before minor procedures (such as a needle stick or minor skin surgery):
    • Exposure time: approx. 1 hour.
  • Newborns and infants aged 0-2 months: A patch containing the active substance is stuck onto the skin area to be treated.
    • Exposure time: maximum 1 hour. Only a single dose should be used in any 24-hour period.
    • Due to its size, the medicated plaster is not suitable for use on certain parts of the body in newborns and infants.
  • Babies aged 3 - 11 months: Up to two medicated plasters are stuck onto the skin area to be treated.
    • Exposure time: approx. 1 hour, maximum 4 hours.
  • Children from 1 - 5 years: Up to 10 plasters containing active ingredients are stuck onto the skin area to be treated.
    • Exposure time: approx. 1 hour, maximum 5 hours.
  • Children from 6 to 11 years: Up to 20 patches containing active ingredients are stuck onto the skin area to be treated.
    • Exposure time: approx. 1 hour, maximum 5 hours.
  • In children over 3 months of age, a maximum of 2 doses may be used within a 24-hour period, as indicated above, 12 hours apart.
  • This preparation can be used on children with neurodermatitis (a skin disease also called "atopic dermatitis"), but the exposure time is then no longer than 30 minutes.
• When applying the medicated patch, it is important that you follow the instructions below exactly:
  • The patch should be applied at least 1 hour before the planned procedure (except for patients with neurodermatitis).
  • If necessary, remove body hair in the affected skin area before use. The medicated plaster should not be cut or divided in any other way.
• Use on the skin prior to mollusc wart removal
  • The patch can be used in children and adolescents with neurodermatitis (a skin disease also called "atopic dermatitis").
  • The usual dose depends on the child's age and is given for 30 to 60 minutes (30 minutes for children/adolescents with eczema). Your doctor, pharmacist or nurse will tell you how many patches to use.

• If you use more patches than you should
  • If you have used more patches than your doctor, pharmacist or nurse has told you to, tell them straight away even if you don't get any symptoms.
  • Symptoms after using too many patches are listed below. It is unlikely that the symptoms will occur if the preparation is used as recommended.
    • Feeling light-headed or dizzy
    • Tingling of the skin around the mouth and numbness of the tongue
    • Unusual taste
    • blurred vision
    • ringing in ears
    • There is also a risk of "acute methaemoglobinaemia" (a problem with blood pigment levels). This is more likely if certain medicines have been taken at the same time. When this occurs, the skin turns a bluish-grey due to lack of oxygen.
  • In severe cases of overdose, signs of illness such as seizures, low blood pressure, slow breathing, stopping breathing and changes in heartbeat may occur.
  • These effects can be life-threatening.

• If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
  

TAPFI, lidocaine, prilocaine, medicated plaster way

• When applying the medicated patch, it is important that you follow the instructions below exactly:
  • It should be applied at least 1 hour before the planned intervention (except for patients with neurodermatitis).
  • If necessary, remove body hair in the affected skin area before use. The medicated plaster should not be cut or divided in any other way.
  • 1. Make sure the area of ​​skin to be numbed is clean and dry.
  • Bend back the excess aluminum wing at the corner of the patch. Now grab the skin-colored side of the patch with your other hand. Make sure both layers are well separated at the corner before continuing.
  • 2. Now pull the adhesive surface and protective film apart as shown in the illustration.
  • Be careful not to touch the white round cushion that contains the active ingredients (lidocaine/prilocaine).
  • 3. Do not press on the center of the medicated patch. This could result in the emulsion leaking out and the adhesive surface not adhering sufficiently. Press the patch firmly around the edges so that it sticks well to the skin.
  • 4. The time it was applied can be noted on the edge of the medicated patch. (A ballpoint pen works well for this.)
  • 5. Leave the patch containing the active ingredient to act for at least 1 hour (exception: patients with neurodermatitis).
  • In children under 3 months, the medicated plaster should not be left on for more than one hour.
  • 6. Remove the medicated plaster after the appropriate exposure time has elapsed.

side TAPFI, lidocaine, prilocaine, medicated plaster effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• If any of the side effects get bothersome or you think they won't go away, talk to your doctor or pharmacist. Tell your doctor about any other condition that makes you feel unwell while using this product.
• A mild reaction (pallor or reddening of the skin, slight swelling, initial burning or itching) may occur on the area where the patch is applied. These are normal reactions to the medicated patch and the anesthetics and they will go away without any action being needed.
• If you experience any unpleasant or unusual effects while using the patch, stop using it and tell your doctor or pharmacist as soon as possible.
• Common (may affect up to 1 in 10 people)
  • Temporary local skin reactions (pallor, redness, swelling) on ​​the treated area
• Uncommon (may affect up to 1 in 100 people)
  • An initial slight burning, itching, or warmth sensation in the treated area
• Rare (may affect up to 1 in 1,000 people)
  • Allergic reactions, which in rare cases can lead to anaphylactic shock (rash, swelling, fever, difficulty breathing and fainting)
  • Methaemoglobinaemia (blood composition disorder)
  • Small, punctiform bleeding on the treated area (especially in children with eczema after a longer period of exposure)
  • Irritation to eyes if emulsion accidentally gets into skin while treating
• Additional side effects in children
  • Methaemoglobinaemia, a blood composition disorder that is observed more commonly, often in association with overdose, in neonates and infants 0 to 12 months of age.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to side effects that are not specified.

TAPFI, lidocaine, prilocaine, medicated plaster interactions

• Use together with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This is because this medicine can affect the way other medicines work and other medicines can have an effect on the patch.
  • In particular, tell your doctor and pharmacist if you or your child have recently used or received any of the following medicines:
    • Medicines used to treat infections: sulfonamides and nitrofurantoin
    • Medicines used to treat epilepsy: phenytoin and phenobarbital
    • Other local anesthetics
    • Cimetidine or beta-blockers, which can cause an increase in the level of lidocaine in the blood. This interaction is not clinically significant with short-term treatment with this patch at recommended doses.

TAPFI, lidocaine, prilocaine, medicated plaster Contraindications

• This medicine must not be used
  • if you are allergic to lidocaine or prilocaine, other similar local anesthetics or any of the other ingredients of this medicine.

pregnancy TAPFI, lidocaine, prilocaine, medicated plaster and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• pregnancy
  • Incidental use during pregnancy is unlikely to adversely affect the fetus.
• lactation
  • The active ingredients (lidocaine and prilocaine) pass into breast milk. However, the amount is so small that there is generally no risk to the child.
• fertility
  • Animal studies have shown no impairment of male or female fertility.

patient TAPFI, lidocaine, prilocaine, medicated plaster notes

• Warnings and Precautions
  • Talk to your doctor, pharmacist or nurse before using this medicine,
    • if you or your child have a rare hereditary disease called "glucose-6-phosphate dehydrogenase deficiency" that affects the blood;
    • if you or your child have a problem with the levels of the blood pigment methemoglobin in the blood, called "methaemoglobinaemia";
    • do not apply the patch to areas with a rash, cuts, abrasions, or other open wounds. If you have any of these problems, talk to your doctor, pharmacist or nurse before using the patch;
    • if you or your child have neurodermatitis (an itchy skin condition, also called "atopic dermatitis"), a shorter exposure time may be sufficient. Exposure time longer than 30 minutes may lead to an increased occurrence of local skin reactions.
  • Avoid getting the medicated emulsion in your eyes as it may cause irritation. If the emulsion accidentally gets into your eye, you should immediately rinse it well with lukewarm water or saline (sodium chloride solution).
  • Be careful not to get anything in your eye until feeling returns.
  • If you use the preparation before vaccinations with live vaccines (e.g. tuberculosis
    vaccination), you should visit your doctor or nurse again within the specified period to check the vaccination result.
  • children and young people
    • In infants/newborns under the age of 3 months, a temporary, clinically insignificant increase in the concentration of the blood pigment methemoglobin in the blood is often observed up to 12 hours after application of the patch ("methaemoglobinaemia").
    • The effectiveness of the patch in blood collection from the heel of newborn babies has not been confirmed in clinical trials.
    • It should not be used in children under 12 months of age who are being treated with other medicines that affect the level of the blood pigment methemoglobin in the blood ("methaemoglobinaemia") (e.g. sulphonamides).
    • The preparation should not be used in premature babies.

• Ability to drive and use machines
  • This preparation has no or negligible influence on the ability to drive and use machines when used at the recommended doses.

TAPFI, lidocaine, prilocaine, medicated plaster